search
Back to results

CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies

Primary Purpose

B Cell Lymphoma, B Cell Leukemia

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 CARvac T cells
Sponsored by
iCell Gene Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B Cell Lymphoma focused on measuring CD19, CD19 CAR T cell

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis based on the World Health Organization (WHO) 2008
  2. Patients have exhausted standard therapeutic options
  3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
  4. Female must be not pregnant during the study

Exclusion Criteria:

  1. Prior solid organ transplantation
  2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
  3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents

Sites / Locations

  • The General Hospital of Western Theater CommandRecruiting
  • Peking University Shenzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CD19 CARvac T cells

Arm Description

CD19 CARvac T cells transduced with a lentiviral vector to express

Outcomes

Primary Outcome Measures

Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Type of dose-limiting toxicity (DLT)
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary Outcome Measures

Overall Response Rate (ORR)
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Progression-free survival (PFS)
Overall survival

Full Information

First Posted
November 6, 2019
Last Updated
November 8, 2019
Sponsor
iCell Gene Therapeutics
Collaborators
Peking University Shenzhen Hospital, Chengdu Military General Hospital, iCAR Bio Therapeutics Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04156243
Brief Title
CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies
Official Title
Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD19 CARvac in Patients With Relapsed and/or Refractory B Cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iCell Gene Therapeutics
Collaborators
Peking University Shenzhen Hospital, Chengdu Military General Hospital, iCAR Bio Therapeutics Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.
Detailed Description
CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma, B Cell Leukemia
Keywords
CD19, CD19 CAR T cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CD19 CARvac T cells
Arm Type
Experimental
Arm Description
CD19 CARvac T cells transduced with a lentiviral vector to express
Intervention Type
Biological
Intervention Name(s)
CD19 CARvac T cells
Intervention Description
CD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
Primary Outcome Measure Information:
Title
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame
28 days
Title
Type of dose-limiting toxicity (DLT)
Time Frame
28 days
Title
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Time Frame
1 year
Title
Progression-free survival (PFS)
Time Frame
1 year
Title
Overall survival
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis based on the World Health Organization (WHO) 2008 Patients have exhausted standard therapeutic options Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks Female must be not pregnant during the study Exclusion Criteria: Prior solid organ transplantation Potentially curative therapy including chemotherapy or hematopoietic cell transplant Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Pinz
Phone
6315386218
Email
kevin.pinz@icellgene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongyu Zhang, MD, PhD
Organizational Affiliation
Peking University Shenzhen Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fang Liu, MD, PhD
Organizational Affiliation
The General Hospital of Western Theater Command
Official's Role
Principal Investigator
Facility Information:
Facility Name
The General Hospital of Western Theater Command
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Liu, MD, PhD
Email
lfyh2006@yahoo.com
Facility Name
Peking University Shenzhen Hospital
City
Shenzhen
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Zhang, MD, PhD
Email
HongyuZhang@pkuszh.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32840736
Citation
Liu F, Sha S, Ma G, Su Y, Xiong Y, He G, Li Y, Hanes WM, Tse W. Treatment of CML-transformed B Cell Acute Lymphoblastic Leukemia (B-ALL) in Adults with Anti-CD19 Chimeric Antigen Receptor T Cell (CAR T) Therapy. Stem Cell Rev Rep. 2020 Dec;16(6):1356-1358. doi: 10.1007/s12015-020-10008-7. No abstract available.
Results Reference
derived

Learn more about this trial

CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies

We'll reach out to this number within 24 hrs